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Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
erlotinib hydrochloride
gemcitabine hydrochloride
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or metastatic disease that is considered unresectable No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past year No cardiac ventricular arrhythmias requiring medication Gastrointestinal: No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) No post-surgical malabsorption characterized by: Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR Requires IV hyperalimentation Pancreatic enzyme supplementation allowed provided that the above criteria are not met Ophthalmic: No ocular inflammation or infection unless fully treated prior to study No significant ophthalmologic abnormalities, including the following: Severe dry eye syndrome Sjogren's syndrome Keratoconjunctivitis sicca Severe exposure keratopathy Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious active infection No other serious underlying medical, psychological, or geographical condition that would preclude study participation No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy or immunotherapy Chemotherapy: No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy for local disease allowed if evidence of disease progression has occurred No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior major surgery No concurrent ophthalmic surgery Other: No prior epidermal growth factor receptor inhibitors At least 2 weeks since prior investigational drug No other concurrent investigational drugs during and for at least 30 days after study No other concurrent anti-cancer therapy

Sites / Locations

  • Arizona Clinical Research Center
  • Highlands Oncology Group
  • Alta Bates Comprehensive Cancer Center
  • Sutter Health West Cancer Research Group
  • Loma Linda University Cancer Institute
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Kenmar Research Institute
  • Century City Hospital
  • David Geffen School of Medicine
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
  • Davis, Posteraro, & Wasser, MDs, LLP
  • New Britain General Hospital
  • Eastern Connecticut Hematology and Oncology Associates
  • Hematology Oncology, P.C.
  • Florida Cancer Specialists
  • Oncology-Hematology Group of South Florida
  • Ocala Oncology Center
  • Oncology & Hematology Associates of West Broward
  • Moffitt Clinic at Tampa General Hospital
  • Central Georgia Hematology Oncology, P.C.
  • Mountain States Tumor Institute
  • Northwest Medical Specialists, P.C.
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Midwest Cancer Research Group, Inc.
  • Carle Cancer Center
  • Medical Consultants
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Lucille Parker Markey Cancer Center, University of Kentucky
  • Norton Healthcare Pavilion
  • Mary Bird Perkins Cancer Center
  • Tulane Cancer Center
  • Annapolis Medical Specialists
  • Sinai Hospital of Baltimore
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Tuft-New England Medical Center
  • St. Elizabeth's Medical Center
  • Berkshire Physicians and Surgeons, P.C.
  • Baystate Medical Center
  • University of Minnesota Cancer Center
  • Midwest Oncology Consortium
  • New Hampshire Oncology-Hematology PA
  • St. Barnabas Medical Center
  • Hematology-Oncology Associates
  • Cooper Cancer Institute
  • Cancer Center at Glens Falls Hospital
  • Arena Oncology Associates
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Beth Israel Medical Center
  • Interlakes Oncology/Hematology PC
  • Staten Island University Hospital
  • University Hospital - Stony Brook
  • Presbyterian Hospital
  • Mid Dakota Clinic, P.C.
  • University Hospitals of Cleveland
  • Earle A. Chiles Research Institute at Providence Portland Medical Center
  • Hematology-Oncology Association of NE Pennsylvania
  • University of Pennsylvania Cancer Center
  • Pennsylvania Oncology Hematology Associates
  • Fox Chase Cancer Center
  • Charleston Hematology-Oncology, P.A.
  • Sarah Cannon-Minnie Pearl Cancer Center
  • Arlington Cancer Center
  • Southwest Regional Cancer Center
  • Texas Cancer Care
  • University of Texas - MD Anderson Cancer Center
  • Tyler Hematology Oncology, P.A.
  • Green Mountain Oncology Group
  • Hematology & Oncology Associates of Virginia
  • Western Washington Oncology
  • Southwest Washington Medical Center
  • Oncology of Wisconsin
  • Hospital Britanico
  • Instituto de Oncologia Angel H. Roffo
  • Instituto Alexander Fleming
  • Hospital Churruca
  • Hospital Italiano
  • Hospital Interzonal De Augudos Euita
  • Confidence Medical Center
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • Newcastle Mater Misericordiae Hospital
  • Institute of Oncology
  • Royal Adelaide Hospital
  • Ashford Cancer Centre
  • Queen Elizabeth Hospital
  • Frankston Hospital
  • Austin and Repatriation Medical Centre
  • Royal Perth Hospital
  • Peter MacCallum Cancer Institute
  • Institut Jules Bordet
  • Nucleo de Oncologia da Bahia
  • Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
  • Hospital Israelita Albert Einstein
  • Cross Cancer Institute
  • British Columbia Cancer Agency - Centre for the Southern Interior
  • Penticton Regional Hospital
  • British Columbia Cancer Agency - Fraser Valley Cancer Centre
  • British Columbia Cancer Agency
  • CancerCare Manitoba
  • Saint John Regional Hospital
  • Newfoundland Cancer Treatment and Research Foundation
  • Queen Elizabeth II Health Science Centre
  • Royal Victoria Hospital, Barrie
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Kingston Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Credit Valley Hospital
  • Southlake Regional Health Centre
  • Ottawa Regional Cancer Centre
  • Peterborough Oncology Clinic
  • Algoma District Medical Group
  • Hotel Dieu Health Sciences Hospital - Niagara
  • Toronto East General Hospital
  • Toronto Sunnybrook Regional Cancer Centre
  • Ontario Cancer Institute
  • Toronto General Hospital
  • Saint Joseph's Health Centre - Toronto
  • Maisonneuve-Rosemont Hospital
  • Hopital Du Sacre-Coeur de Montreal
  • L'Hopital Laval
  • Allan Blair Cancer Centre
  • Clinica Las Condes
  • Pamela Youde Nethersole Eastern Hospital
  • Queen Mary Hospital
  • Virchow Klinikum Humboldt Universitaet Berlin
  • Universitaetsklinik und Strahlenklinik - Essen
  • Stadtische Kliniken Frankfurt-Hochst
  • Tumor Biology Center at the Albert - Ludwigs University
  • Martin Luther Universitaet
  • Medizinische Universitaetsklinik und Poliklinik
  • Universitatsklinik, Saarland
  • University Wurzburg
  • University Hospital of Heraklion
  • Theagenio Medical Institute
  • Hippokration Hospital
  • Prince of Wales Hospital
  • Haemek Medical Center
  • Rambam Medical Center
  • Rabin Medical Center - Beilinson Campus
  • Rabin Medical Center - Golda-Hasharon Campus
  • Kaplan Hospital
  • Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Policlinico - Cattedra di Ematologia
  • Instituto Nac de Cancerologia
  • Centro Estatal de Cancerologia
  • Auckland Hospital
  • Christchurch Hospital
  • Great Poland Cancer Center
  • Dolnoslaskie Centrum Oncology
  • Institute of Oncology - Bucarest
  • Institutul Oncologic-Universitatea de Medicina
  • St. Spiridon University Hospital
  • Clinical County Hospital of Sibiu
  • National University Hospital
  • Singapore General Hospital
  • National Cancer Centre - Singapore
  • Queen Elizabeth Hospital
  • North Middlesex Hospital
  • St. Luke's Cancer Center
  • Princess Royal Hospital
  • Saint Bartholomew's Hospital
  • Guy's and St. Thomas' Hospitals NHS Trust
  • Christie Hospital N.H.S. Trust
  • Northern Centre for Cancer Treatment
  • Royal South Hants Hospital
  • New Cross Hospital
  • Belfast City Hospital Trust
  • Velindre Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

OSI-774 plus Gemcitabine

Placebo plus gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression free survival
Quality of Life
Canada, US and selected countries only
Response rates
Complete and partial response only.
Toxicity
EGFR levels
Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
Pharmacokinetics
To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics

Full Information

First Posted
November 9, 2001
Last Updated
March 31, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00026338
Brief Title
Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
Official Title
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2001 (Actual)
Primary Completion Date
September 17, 2004 (Actual)
Study Completion Date
February 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
Detailed Description
OBJECTIVES: Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib. Compare the progression-free survival rate in patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare the response rate and response duration in patients treated with these regimens. Compare the nature, severity, and frequency of toxic effects of these regimens in these patients. Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens. Determine the pharmacokinetics of erlotinib in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, extent of disease (locally advanced vs metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib once daily. Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent courses, at 4 weeks after study, and then every 12 weeks until disease progression. Patients are followed at 4 weeks and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSI-774 plus Gemcitabine
Arm Type
Active Comparator
Arm Title
Placebo plus gemcitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Description
150 mg po daily
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 years
Title
Quality of Life
Description
Canada, US and selected countries only
Time Frame
3 years
Title
Response rates
Description
Complete and partial response only.
Time Frame
3 years
Title
Toxicity
Time Frame
3 years
Title
EGFR levels
Description
Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
Time Frame
3 years
Title
Pharmacokinetics
Description
To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or metastatic disease that is considered unresectable No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past year No cardiac ventricular arrhythmias requiring medication Gastrointestinal: No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) No post-surgical malabsorption characterized by: Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR Requires IV hyperalimentation Pancreatic enzyme supplementation allowed provided that the above criteria are not met Ophthalmic: No ocular inflammation or infection unless fully treated prior to study No significant ophthalmologic abnormalities, including the following: Severe dry eye syndrome Sjogren's syndrome Keratoconjunctivitis sicca Severe exposure keratopathy Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious active infection No other serious underlying medical, psychological, or geographical condition that would preclude study participation No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy or immunotherapy Chemotherapy: No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy for local disease allowed if evidence of disease progression has occurred No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior major surgery No concurrent ophthalmic surgery Other: No prior epidermal growth factor receptor inhibitors At least 2 weeks since prior investigational drug No other concurrent investigational drugs during and for at least 30 days after study No other concurrent anti-cancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm J. Moore, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Sutter Health West Cancer Research Group
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Loma Linda University Cancer Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Century City Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7059
Country
United States
Facility Name
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Davis, Posteraro, & Wasser, MDs, LLP
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050-2000
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471-5563
Country
United States
Facility Name
Oncology & Hematology Associates of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Moffitt Clinic at Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Central Georgia Hematology Oncology, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Northwest Medical Specialists, P.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Midwest Cancer Research Group, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Medical Consultants
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7353
Country
United States
Facility Name
Lucille Parker Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Annapolis Medical Specialists
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Tuft-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135-2997
Country
United States
Facility Name
Berkshire Physicians and Surgeons, P.C.
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Midwest Oncology Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New Hampshire Oncology-Hematology PA
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Hematology-Oncology Associates
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Cooper Cancer Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Cancer Center at Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Arena Oncology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Interlakes Oncology/Hematology PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University Hospital - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8174
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Mid Dakota Clinic, P.C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502-5538
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Earle A. Chiles Research Institute at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Hematology-Oncology Association of NE Pennsylvania
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Charleston Hematology-Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Sarah Cannon-Minnie Pearl Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Tyler Hematology Oncology, P.A.
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Hematology & Oncology Associates of Virginia
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Western Washington Oncology
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Southwest Washington Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Oncology of Wisconsin
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
Hospital Britanico
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Instituto de Oncologia Angel H. Roffo
City
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
Instituto Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Churruca
City
Buenos Aires
ZIP/Postal Code
1437
Country
Argentina
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
CP1181ACH
Country
Argentina
Facility Name
Hospital Interzonal De Augudos Euita
City
Lanus
ZIP/Postal Code
1824
Country
Argentina
Facility Name
Confidence Medical Center
City
San Isidro
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
NSW 2310
Country
Australia
Facility Name
Institute of Oncology
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Centre
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin and Repatriation Medical Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
ZIP/Postal Code
8006
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Nucleo de Oncologia da Bahia
City
Bahia
ZIP/Postal Code
40170-070
Country
Brazil
Facility Name
Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
City
Porto Alegre
ZIP/Postal Code
91330-490
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Penticton Regional Hospital
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 3G6
Country
Canada
Facility Name
British Columbia Cancer Agency - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Newfoundland Cancer Treatment and Research Foundation
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Queen Elizabeth II Health Science Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Royal Victoria Hospital, Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Peterborough Oncology Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 7B6
Country
Canada
Facility Name
Algoma District Medical Group
City
Sault Sainte Marie
State/Province
Ontario
ZIP/Postal Code
P6B 1Y5
Country
Canada
Facility Name
Hotel Dieu Health Sciences Hospital - Niagara
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 5K3
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Ontario Cancer Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada
Facility Name
Saint Joseph's Health Centre - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
L'Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Clinica Las Condes
City
Santiago
Country
Chile
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Virchow Klinikum Humboldt Universitaet Berlin
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Stadtische Kliniken Frankfurt-Hochst
City
Frankfurt
ZIP/Postal Code
DOH-65929
Country
Germany
Facility Name
Tumor Biology Center at the Albert - Ludwigs University
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Martin Luther Universitaet
City
Halle
ZIP/Postal Code
DOH-06112
Country
Germany
Facility Name
Medizinische Universitaetsklinik und Poliklinik
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Germany
Facility Name
Universitatsklinik, Saarland
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
University Wurzburg
City
Wurzburg
ZIP/Postal Code
D-97070
Country
Germany
Facility Name
University Hospital of Heraklion
City
Iraklion (Heraklion)
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Theagenio Medical Institute
City
Thessaloniki
ZIP/Postal Code
540 07
Country
Greece
Facility Name
Hippokration Hospital
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
ZIP/Postal Code
NT
Country
Hong Kong
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Campus
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Rabin Medical Center - Golda-Hasharon Campus
City
Petah-Tikva
ZIP/Postal Code
49372
Country
Israel
Facility Name
Kaplan Hospital
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Policlinico - Cattedra di Ematologia
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Instituto Nac de Cancerologia
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
22
Country
Mexico
Facility Name
Centro Estatal de Cancerologia
City
Dviango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Auckland Hospital
City
Auckland
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Great Poland Cancer Center
City
Poznan
ZIP/Postal Code
61 866
Country
Poland
Facility Name
Dolnoslaskie Centrum Oncology
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Institute of Oncology - Bucarest
City
Bucarest
ZIP/Postal Code
RO 72435
Country
Romania
Facility Name
Institutul Oncologic-Universitatea de Medicina
City
Cluj-Napoca
ZIP/Postal Code
3400
Country
Romania
Facility Name
St. Spiridon University Hospital
City
Lasi
ZIP/Postal Code
6600
Country
Romania
Facility Name
Clinical County Hospital of Sibiu
City
Sibiu
ZIP/Postal Code
2400
Country
Romania
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
168609
Country
Singapore
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
Edmonton, London
State/Province
England
ZIP/Postal Code
NI8 1QX
Country
United Kingdom
Facility Name
St. Luke's Cancer Center
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospitals NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment
City
Newcastle upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Belfast City Hospital Trust
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Dhani NC, Tu D, Parulekar W, et al.: A retrospective analysis of tumor size (TS) as a continuous rather than discrete variable in advanced pancreatic cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-e15565, 2009.
Results Reference
background
Citation
Moore MJ, da Cunha Santos G, Kamel-Reid S, et al.: The relationship of K-ras mutations and EGFR gene copy number to outcome in patients treated with Erlotinib on National Cancer Institute of Canada Clinical Trials Group trial study PA.3. [Abstract] J Clin Oncol 25 (Suppl 18): A-4521, 2007.
Results Reference
result
PubMed Identifier
17452677
Citation
Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. doi: 10.1200/JCO.2006.07.9525. Epub 2007 Apr 23.
Results Reference
result
Citation
Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib improves survival when added to gemcitabine in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-77, 2005.
Results Reference
result

Learn more about this trial

Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

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